510(k) Review Periods Shortening for Biomarker Tests


We are beginning to update our research report that analyzes commercial trends for biomarker-based tests, and one of the first numbers we looked at is the average FDA review period for 510(k) tests that use molecular biomarkers. In our last report the trend over the last decade (2002-2012) was discouraging, with FDA taking an average of three times as long to clear a biomarker-based IVD test in 2012 as it did early in the decade.

2012 was, however, the first year since 2006 that the average review period actually shortened compared to the prior year, and our initial analysis for 2013 shows yet another reduction in review period compared to 2012. The average review period for a biomarker-based 510(k) test was 233 days in 2013, 14 days shorter than 2012, and the total reduction in average review period since the beginning of 2012 is 38 days. That’s a 15% reduction in average review period in two years for tests that utilize biomarkers.

Average FDA Review Periods for 510(k)-Cleared IVD Tests, by Year Cleared
This chart shows the average length of time (in days) that FDA took to clear IVD tests that utilize molecular biomarkers, by the year in which the tests were cleared. The error bars represent the standard deviation in days.

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